(268 days)
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCI), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
Pump tubing-flexis used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first. Time per contrast media or saline container depends on each contrast media's or saline's use time expiration with a maximum of eight (8) hours per contrast media or saline container.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects underqoing diagnostic examinations in computed tomography (CT) applications.
The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:
- . Spike for CT
- . Pump tubing-flex
- . Patient Tubing
ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex, and patient tubing for pump tubing-flex).
The updated ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:
- Multiple patient use saline containers, .
- Omnipaque IBP contrast media containers, .
- . Omnipaque single-dose contrast media bottles,
- . Visipaque single-dose contrast media bottles, and
- . Cannula.
The updated ulrichINJECT CT motion system is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the device. Controls include air detectors, which are designed to detect air without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulrichINJECT CT motion is provided in three versions:
- . Mobile pedestal version
- Ceiling version ●
- Wall mounted version ●
This document describes the ulrichINJECT CT motion, a syringeless contrast media management system for CT applications. The submission to the FDA (K192872) is seeking to market the device as substantially equivalent to a previously cleared version (K171392). The main changes mentioned are the support for additional contrast media (Omnipaque single dose and Visipaque single dose) and a new Li-ion battery option.
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, concise format. Instead, it details various non-clinical tests performed and states that the device "complies with the standards listed" or "met the requirements of the pre-defined acceptance criteria."
Therefore, I will extrapolate the acceptance criteria and performance based on the described tests and the "Comparison" column in the detailed comparison table, where the subject device is deemed "identical" or "equivalent" to the predicate.
Extrapolated Acceptance Criteria and Reported Device Performance (Based on "Comparison" and "Non-Clinical Testing" sections):
| Acceptance Criteria Category | Performance Criterion (Extrapolated) | Reported Device Performance (Summary from document) |
|---|---|---|
| Indications for Use | Be indicated for controlled, automatic administration of contrast media and saline on the venous side for CT applications. Support Omnipaque™ IBP, Omnipaque™ single dose, and Visipaque™ single dose. Maintain specified tubing use times (Pump tubing-flex 24 hours, Patient tubing per patient, Spike for CT single bottle). | Met. Intended use and indications are identical to predicate, with the addition of Omnipaque single dose and Visipaque single dose, which are stated not to affect intended use or safety/effectiveness. Tubing use times are identical to predicate. |
| System Components | Injector Head, Touch Terminal, Injector Base, Wall Mount, Ceiling Mount, Contrast Media Housing with Heater, and specified disposables (Pump Tubing-flex, Patient Tubing, Spike for CT) must be present and function as per predicate. | Met. System components and disposables are identical to the predicate (K171392). |
| Physical Design | Weight, dimensions, and power requirements must be identical to predicate. | Met. Weight, dimensions, and power requirements are identical to predicate. |
| Battery | New Li-Ion battery must not affect intended use, safety, or effectiveness. | Met. The new Li-Ion battery option is a difference from the predicate but is stated not to affect the intended use, safety, or effectiveness of the device. (Implies testing was done to confirm this, though specific results aren't detailed in the table). |
| Display Type | Color LCD Terminal with touch screen. | Met. Identical to predicate. |
| Operational Characteristics | Syringeless system, remote operation via Touch Terminal, single-patient use disposable (Patient Tubing), prevention of reusable disposables via software, rotary peristaltic pump, administration of contrast media and saline, use of spikes for media containers. | Met. All operational characteristics are identical to the predicate. |
| Safety Mechanisms | Multi-layered software stops, used Patient Tubing/Pump Tubing-flex detectors, volume remaining readout (if programmed > remaining), programmable pressure limit (195 PSI), safety feature against reuse of patient tubing and spikes. | Met. All safety mechanisms are identical to the predicate. |
| Injection Capabilities | 40 phases per protocol. Injection rates for contrast media and saline (0.1 mL/s to 10.0 mL/s). Injection volume (1-200 mL contrast, 400 mL total media per patient). Injection pause (0-999 sec). Injection protocol storage. Priming/Venting Rate (2 mL/s manual). | Met. All injection capabilities are identical to the predicate. |
| Flow Rate and Volume Accuracy | Volume accuracy of ± 5% for 10-200 mL contrast media. Flow rate accuracy of ± 5%. | Met. Identical to predicate. |
| Compatible Contrast Media | Must be compatible with Omnipaque™ IBP, Omnipaque™ single dose, and Visipaque™ single dose, without compromise to chemical integrity. | Met. Chemical compatibility testing concluded the system does not interact with Omnipaque™ or Visipaque™, and their chemical integrity is not compromised. This difference from the predicate was addressed with contamination control, extractables/leachables studies, and bench testing. |
| Contrast Media Container Volume | System supports 500 mL (OMNIPAQUE™ IBP), 100 mL and 150 mL (VISIPAQUE™ single dose), 150 mL (OMNIPAQUE™ single dose). | Met. Equivalent to predicate; additional volumes for Omnipaque and Visipaque addressed with a process simulation study. |
| Air Detection | Ultrasound principle. Technical detection limit of air in tubing 0.05 mL. Air detector alarm limit 1 mL. | Met. Identical to predicate. |
| Occlusion Detection | Fail-safe piezo-resistive pressure sensor principle. Occlusion detection alarm limit 246 PSI. | Met. Identical to predicate. |
| Sterilization | EtO sterilization to a sterility assurance level of 10-6 in accordance with ISO 11135-1. Packaging validated per ISO 11607-1. | Met. Verification results indicate compliance with ISO 11135-1 and ISO 11607-1. |
| Shelf-Life | Real-time and accelerated aging studies confirm specified shelf-life. | Met. Additional real-time aging shelf-life data provided for this submission. The ulrichINJECT CT motion tubing system's packaging was validated per ISO 11607-1. |
| Contamination Control | Ability to maintain sterility and resist microorganism ingress with Omnipaque IBP, Omnipaque single dose, and Visipaque single dose. Residuals between active compounds within defined limits after rinsing. | Met. Studies (Process Simulation, Microbial Ingress, Cross Contamination, Rinsing) concluded the device maintains sterility and resists ingress with the listed contrast media, and residuals are within defined limits. |
| Biocompatibility | Indirect patient contact materials verified per ISO 10993-1, including tests for cytotoxicity, intracutaneous reactivity, allergic sensitization, systemic acute toxicity, pyrogens, hemocompatibility (hemolysis), and LAL test. | Met. Verification results indicated compliance with ISO 10993-1 for the listed tests. |
| Extractables and Leachables | Testing and toxicological assessment demonstrate safety and effectiveness for intended uses, meeting pre-defined acceptance criteria for Omnipaque and Visipaque. | Met. Testing for extractables and leachables for VISIPAQUE, along with a toxicological assessment, met pre-defined acceptance criteria, demonstrating safety and effectiveness. (OMNIPAQUE testing was previously done for K171392). |
| Performance - Bench | Conformance to predetermined specifications and applicable standards (e.g., applicable requirements from ISO 8536-4). Confirmation that mixing of contrast media will not occur. | Met. Testing confirmed conformance to specifications and applicable standards. Additional verification testing confirmed no mixing of contrast media. Transport validation and cleaning instructions validation were also performed. |
| Software Validation | Conformance with established performance criteria through Installation Qualification and Operational/Performance Qualification, following FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005). | Met. Software V&V was repeated for updates, following FDA guidance. IQ and O/PQ criteria were met, and the software was released for intended use. |
| Electromagnetic Compatibility / Electrical Safety | Conformance with IEC 60601-1 and related collateral standards (e.g., IEC 60601-1-2 4th edition). | Met. Testing results indicate compliance with IEC 60601-1, IEC 60601-1-2 (4th edition). |
Study Information:
The provided document describes a 510(k) submission (K192872) for the ulrichINJECT CT motion system. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a predicate device (K171392), rather than prove de novo safety and effectiveness through extensive clinical trials. Therefore, the "studies" described are primarily non-clinical verification and validation activities.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Test Set Sample Size:
- For physical components and engineering performance (Flow Rate, Volume Accuracy, Pressure Limits, Air Detection, etc.): The document does not specify a numerical sample size for bench tests. It refers to "verification testing" and "additional verification testing," implying that a sufficient number of tests were conducted to confirm performance parameters against established specifications and standards.
- For chemical compatibility, contamination control, biocompatibility, and extractables/leachables: These tests typically involve a sample of the device materials and exposure to the specified substances or conditions, but a specific number is not provided.
- For software validation: No specific number of test cases or iterations is provided, but it states "Validation included an installation qualification and an operational / performance qualification."
-
Data Provenance: The studies are non-clinical (bench testing, lab studies). The country of origin of the data is not explicitly stated, but the submitter (ulrich GmbH & Co. KG) is located in Germany. These studies are prospective in the sense that they were conducted specifically for this submission to address the changes and confirm substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. For this type of non-clinical, engineering, and laboratory-based verification and validation, "ground truth" as established by human experts (like radiologists) is not the primary method. Instead, "ground truth" is typically defined by:
- Established engineering specifications and performance targets.
- International and national consensus standards (e.g., ISO, IEC).
- Regulatory guidance documents (e.g., FDA software guidance).
- Pre-defined acceptance criteria derived from these specifications and standards.
- Laboratory analysis results (e.g., chemical assays, microbiological cultures, physical measurements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies involving human interpretation or subjective assessments. The studies presented here are non-clinical verification and validation tests, where results are typically objectively measured against predefined criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is an angiographic injector, a hardware-based system for delivering contrast media, not an AI software intended for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical injector system with embedded software, not a standalone algorithm or AI software. Its performance is inherent to its mechanical and electronic function, although the software controls are crucial for its operation. The performance described is "algorithm only" in the sense that it's the device's intrinsic mechanical/software behavior being tested, but not an AI algorithm performing a diagnostic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical studies relies on:
- Engineering specifications and design requirements: For physical dimensions, weights, power, injection rates, volumes, accuracies, and programmable limits.
- Consensus standards: Such as ISO 11135-1 (sterilization), ISO 11607-1 (packaging), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-1-2 (electrical safety, EMC), and applicable parts of ISO 8536-4 (infusion equipment).
- Laboratory test results: For chemical compatibility, extractables and leachables (chemical analysis), and contamination control (microbiological assays).
- Software validation protocols: Defining expected behavior and outputs.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The software validation refers to qualification, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable. As there is no machine learning "training set," there is no "ground truth" established for it.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.